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BioFire Diagnostics, LLC recalls In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Recalled March 22, 2023 · FDA recall Z-1253-2023 · BioFire Diagnostics
Hazard
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays. · FDA Class II
Units
2 kits
Sold at
U.S. Nationwide distribution in the states of FL and GA.
Description
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Product
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →